The finalized EU GMP Annex 1 “Manufacture of Sterile Medicinal Products” comes into force 25 August 2023. To download the Annex 1 document, visit the European Commission’s official website. The Annex 1 document came to fruition as the Parental Drug Association (PDA) coordinated 11 professional associations in Europe, working together under the umbrella of the European Federation of Pharmaceutical Industries and Associations (EFPIA) to clarify regulations and requirements for the manufacturing of sterile medicinal products. PDA, along with the European Medicines Agency (EMA) and the Inspectors Working Group, took the lead on the discussion of the Annex 1 topic and its drafting.
As manufacturers and contract development and manufacturing organizations (CDMOs) prepare to meet the implementation date, PDA is hard at work writing "Points to Consider" (PtC) technical documents. Among the topics the documents will cover are breaking down the Annex 1 requirements to the science and technology behind them, insights on how to implement the requirements, and efforts to clarify nuanced interpretations that have been arising.
